Guidance

UK-specific annotations to ICH E8

Updated 9 March 2026

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for General Considerations For Clinical Studies (henceforth referred to as ICH E8) is an international guideline that provides an overall introduction to clinical development, designing quality into clinical studies and focusing on those factors critical to the quality of the studies.  

In places, ICH E8 includes references to applicable regulatory requirements or similar in the relevant ICH region. This document is intended to support those involved in running clinical trials in the UK to comply with ICH E8 by specifying what the applicable regulatory requirements or relevant guidance documents are for the UK. 

Note that ‘the Clinical Trials Regulations’ refers to the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

ICH E8 text	Annotation
2.1 The confidentiality of information that could identify participants should be protected in accordance with the applicable regulatory and legal requirement(s) 5.7 Regulations related to protection of individuals’ data need to be followed.	The applicable data protection requirements for the UK are set out in the UK General Data Protection Regulation and the Data Protection Act 2018. The Health Research Authority has further guidance available on UK GDPR for both researchers and study co-ordinators and for data protection officers, information governance officers and research governance managers.
2.2 Early engagement with regulatory authorities to understand local/regional requirements and expectations is encouraged and will facilitate the ability to design quality into the study. 4 Efficient drug development includes appropriately planned interactions with regulatory authorities throughout development to ensure alignment with requirements for product quality and to support approval in the condition or disease.	Sponsors can ask the MHRA for scientific advice at any stage of the medicine’s development or regulation.
4.3.4 Post-approval studies may be conducted to address a regulatory requirement.	Under regulations 59 and 61 of the Human Medicines Regulations 2012, the MHRA is able to grant a marketing authorisation subject to further post-authorisation studies (e.g. post-authorisation efficacy studies (PAES) or post-authorisation safety studies (PASS). Note that non-interventional PASS studies (NI-PASS) must be conducted in accordance with Part 11 and Schedule 12A of the Human Medicines Regulations 2012 for Category 1 products and Part 11 of the Human Medicines Regulations 2012 and Commission Implementing Regulation (EU) No 520/2012 for Category 2 products. Interventional PASS studies are considered to be clinical trials and must be conducted in accordance with the Clinical Trials Regulations. The MHRA has further guidance available on post-authorisation safety studies. Sponsors should also refer to the EMA Guideline on good pharmacovigilance practices (GVP) – Module VIII as modified by the MHRA guidance Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA.
5.7 When considering data from external sources, it is important to ascertain whether the regulatory authorities accept the use of such data for purposes other than the original intent.	Advice on use of external data sources in clinical studies in the UK can be found in the MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions. Sponsors interested in the use of real-world data in their development programmes are also encouraged to seek scientific advice from the MHRA on specific proposals.